Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real‐world results from 18 378 patients in Egypt

Summary Background Treatment of chronic hepatitis C using combination of sofosbuvir ( SOF ) and daclatasvir ( DCV ) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1‐3. The national program in Egypt is using SOF ‐ DCV combination for large scale treatment. Aim To assess the efficacy and safety of combined SOF ‐ DCV in treating patients with HCV ‐G4 in a real‐world setting. Methods Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin ( RBV ) within the national hepatitis C treatment program in Egypt are presented. Treatment‐naïve patients without cirrhosis were treated without RBV , and those who had cirrhosis or were treatment‐experienced (interferon experienced or SOF experienced) received RBV . Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post‐treatment week 12 ( SVR 12) were explored. Results During the first 2 months of the programme, 18 378 patients with HCV ‐G4 started treatment with SOF ‐ DCV with or without RBV . Overall, 95.1% achieved SVR 12 (95.4% among patients treated without RBV and 94.7% for patients treated with RBV , P = .32). Treatment was prematurely discontinued in only 1.5% of patients. The most common events leading to discontinuation were patient withdrawal ( n = 76) and pregnancy ( n = 5). Five deaths occurred within this group. Conclusions Real‐world experience of generic SOF ‐ DCV in patients with chronic HCV ‐G4 proved to be safe and associated with a high SVR 12 rate, in patients with different stages of fibrosis.